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NCT01850524 · OUTCOME

OS in High-risk Population Carrying Del(17p), t(4;14), or t(14;16) Mutations

IXAZOMIB Plus Lenalidomide and Dexamethasone Versus Placebo Plus Lenalidomide and Dexamethasone in Adult Patients With Newly Diagnosed Multiple Myeloma · Source last updated 2023-07-21

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEDIAN
Unit
months
Interval / dispersion
95% Confidence Interval
Time frame
From the date of randomization to death due to any cause (Up to approximately 9 years)

What was measured

OS was defined as the time from the date of randomization to the date of death, as assessed in high-risk population carrying del(17p), t(4;14), or t(14;16) mutations. High risk category includes t(4;14), t(14;16), or del(17) abnormalities.

Analysis population: ITT population included all participants who were randomized. Overall number of participants analyzed indicates the number of participants from the high-risk category.

Groups in this outcome

Placebo + LenDex

Participants who were randomly assigned to receive placebo matching capsule single oral dose on Days 1, 8 and 15 along with standard regimen of LenDex (lenalidomide 25 mg capsules orally on Days 1-21 and dexamethasone 40 mg tablets orally on Days 1, 8, 15 and 22) for the first 18 cycles (each cycle was of 28 days). Following Cycle 18, participants received 3.0 mg ixazomib matching placebo capsule as single oral dose on Days 1, 8 and 15 along with lenalidomide 10 mg capsules orally on Days 1-21 in each 28-day cycle until progressive disease or unacceptable toxicity, whichever comes first up to end of study (up to approximately 109 months).

Ixazomib + LenDex

Participants who were randomly assigned to receive Ixazomib 4.0 mg capsule single oral dose on Days 1, 8 and 15 along with standard regimen of LenDex (lenalidomide 25 mg capsules orally on Days 1-21 and dexamethasone 40 mg tablets orally on Days 1, 8, 15 and 22) for the first 18 cycles (each cycle was of 28 days). Following Cycle 18, participants received 3.0 mg ixazomib capsule as single oral dose on Days 1, 8 and 15 along with lenalidomide 10 mg capsules orally on Days 1-21 in each 28-day cycle until progressive disease or unacceptable toxicity, whichever comes first up to end of study (up to approximately 109 months).

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Placebo + LenDex63
Ixazomib + LenDex60

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Placebo + LenDex43.1Not reported33.8457.82Not reported
Ixazomib + LenDex39.0Not reported25.43NAUpper range of CI was not estimable due to insufficient number of participants with events.

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Lower Limit
    0.678
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.845
    estimate Comment
    Hazard ratio is based on an unadjusted Cox's proportional hazard regression model stratified by age (\<75 years vs \>=75), ISS (stage I or II vs stage III), and BPI-SF worst pain score (\<4 vs \>=4) at screening.
    group Description
    OS in High-risk Population Carrying Del(17p), Amp(1q21), t(4;14), or t(14;16) Mutations
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.662
    param Type
    Hazard Ratio (HR)
    param Value
    1.118
    statistical Comment
    Log-rank test is stratified by age (\<75 years vs \>=75), ISS (stage I or II vs stage III), and BPI-SF worst pain score (\<4 vs \>=4) at screening.
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.678
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.845
    estimate Comment
    Hazard ratio is based on an unadjusted Cox's proportional hazard regression model stratified by age (\<75 years vs \>=75), ISS (stage I or II vs stage III), and BPI-SF worst pain score (\<4 vs \>=4) at screening.
    group Description
    OS in High-risk Population Carrying Del(17p), Amp(1q21), t(4;14), or t(14;16) Mutations
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.662
    param Type
    Hazard Ratio (HR)
    param Value
    1.118
    statistical Comment
    Log-rank test is stratified by age (\<75 years vs \>=75), ISS (stage I or II vs stage III), and BPI-SF worst pain score (\<4 vs \>=4) at screening.
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        33.84
        upper Limit
        57.82
        value
        43.1
      2. comment
        Upper range of CI was not estimable due to insufficient number of participants with events.
        group Id
        OG001
        lower Limit
        25.43
        upper Limit
        NA
        value
        39.0
denoms
  1. counts
    1. group Id
      OG000
      value
      63
    2. group Id
      OG001
      value
      60
    units
    Participants
description
OS was defined as the time from the date of randomization to the date of death, as assessed in high-risk population carrying del(17p), t(4;14), or t(14;16) mutations. High risk category includes t(4;14), t(14;16), or del(17) abnormalities.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants who were randomly assigned to receive placebo matching capsule single oral dose on Days 1, 8 and 15 along with standard regimen of LenDex (lenalidomide 25 mg capsules orally on Days 1-21 and dexamethasone 40 mg tablets orally on Days 1, 8, 15 and 22) for the first 18 cycles (each cycle was of 28 days). Following Cycle 18, participants received 3.0 mg ixazomib matching placebo capsule as single oral dose on Days 1, 8 and 15 along with lenalidomide 10 mg capsules orally on Days 1-21 in each 28-day cycle until progressive disease or unacceptable toxicity, whichever comes first up to end of study (up to approximately 109 months).
    id
    OG000
    title
    Placebo + LenDex
  2. description
    Participants who were randomly assigned to receive Ixazomib 4.0 mg capsule single oral dose on Days 1, 8 and 15 along with standard regimen of LenDex (lenalidomide 25 mg capsules orally on Days 1-21 and dexamethasone 40 mg tablets orally on Days 1, 8, 15 and 22) for the first 18 cycles (each cycle was of 28 days). Following Cycle 18, participants received 3.0 mg ixazomib capsule as single oral dose on Days 1, 8 and 15 along with lenalidomide 10 mg capsules orally on Days 1-21 in each 28-day cycle until progressive disease or unacceptable toxicity, whichever comes first up to end of study (up to approximately 109 months).
    id
    OG001
    title
    Ixazomib + LenDex
param Type
MEDIAN
population Description
ITT population included all participants who were randomized. Overall number of participants analyzed indicates the number of participants from the high-risk category.
reporting Status
POSTED
time Frame
From the date of randomization to death due to any cause (Up to approximately 9 years)
title
OS in High-risk Population Carrying Del(17p), t(4;14), or t(14;16) Mutations
type
SECONDARY
unit Of Measure
months

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Preserved source evidence · Not medical advice